NCT07273877

A Real-World Study on the Treatment of Hypertension With Netrod-RDN Renal Artery Radiofrequency Ablation System

Main Objective: To Evaluate the Long-term Safety and Efficacy of Using the Netrod-RDN Renal Artery Radiofrequency Ablation System in Treating Patients With Refractory Hypertension and Those With Hypertension Who Are Intolerant to Medication in the Real-world Setting

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Shanghai Golden Leaf MedTec Co. Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is an observational one, collecting real-world data generated in routine clinical treatment. The Netrod-RDN renal artery radiofrequency ablation system (including the renal artery radiofrequency ablation device and the disposable mesh renal artery radiofrequency ablation catheter) produced and provided by Shanghai Meiliweiye Medical Technology Co., Ltd. was used to perform percutaneous renal denervation (RDN) on patients with refractory hypertension and drug intolerance in the real world. Refractory hypertension is defined as patients whose blood pressure remains uncontrolled despite taking three or more antihypertensive drugs (including one diuretic) for more than three months; drug intolerance refers to patients who have contraindications to drugs or cannot tolerate drug administration due to adverse drug reactions.

Detailed description

All the subjects who were enrolled and received RDN treatment were followed up until 36 months after the surgery. Blood pressure was measured and the antihypertensive effect was evaluated at regular intervals at 7 days after RDN or before discharge (whichever came first), 30 days (±7 days) after the surgery, 3 months (±14 days), 6 months (±30 days), 12 months (±30 days), 24 months (±30 days), and 36 months (±30 days) during the follow-up. Dynamic safety data monitoring was conducted for the subjects throughout the entire study process.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure	The disposable mesh renal artery radiofrequency ablation catheter is a spiral-arranged 6-point mesh system. Once The use of a meshed renal artery radiofrequency ablation catheter in combination with a dedicated renal artery radiofrequency ablation device delivers radiofrequency energy to the inner wall of the renal artery, generating appropriate high temperatures to damage or partially damage the renal sympathetic nerves. This device has real-time temperature, power and impedance monitoring functions, providing real-time ablation feedback. It also has the function of real-time recording of ablation data and saving the data.

Timeline

• Start date: 2025-08-07
• Primary completion: 2026-03-30
• Completion: 2030-12-30
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: China